In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus
Stopped early · Phase 1/Phase 2
Conditions studied: Graft Versus Host Disease
In brief
In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine
Key facts
- Study ID
- NCT01453140
- Run by
- Hackensack Meridian Health
- People needed
- 3
- Starts
- 2011-08-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus- host disease defined as graft versus host disease (GVHD) occurring within the first 100 days of transplantation
- Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy.
- Progression is defined as up-grading
- No response is defined as no down-grading
- Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent.
- No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent.
- Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria
- Age 18-70
- Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment.
- Serum creatinine < 2 mg/dL
You may not qualify if…
- Patients cannot have active central nervous system (CNS) disease.
- Patients must not have received cyclophosphamide for GVHD prophylaxis
- Patients must not have pneumonia requiring oxygen supplementation
- Unable or unwilling to sign informed consent.
Where it is running
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
Full record on ClinicalTrials.gov
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